Chemistry, Manufacturing and Controls (CMC) Consultancy

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Ensuring safe and effective products through well-defined drug substances and test methods

To appropriately manufacture a pharmaceutical or biological product, a well-defined drug substance and product, manufacturing process and test methods must be developed in order to ensure that the product is safe, effective and consistent between batches. This is a prerequisite to get regulatory approval to study an investigational medicinal product on humans. Collectively, these activities are known as CMC, chemistry, manufacturing and control. CMC plays a crucial role in all stages of the product life cycle including early and late phases of development and even after marketing authorization when the product is on the market. CMC covers a wide range of activities including product, process and test method development, product stability testing, phase appropriate validation, and manufacturing and testing under GMP conditions.

Venn’s CMC experts seamlessly integrate with your in-house team

Through a diverse team of highly-qualified and experienced Project Managers, Technical Leaders, CMC Regulatory Specialists and Quality/GMP specialists, we offer expert consulting services that cover all aspects and stages of Chemistry, Manufacturing, and Controls (CMC) pharmaceutical and biological product development supporting small, midsize and large (bio)pharma companies. Venn’s CMC experts can seamlessly integrate with your in-house experts and participate in multi-disciplinary development teams to facilitate your product, process and method development.

Venn Life Sciences can support you in:

CMC management and strategy development

  • Defining CMC development strategy
  • CMC Project Management
  • Technical CMC due diligence and gap analyses
  • CDMO selection and management
  • QbD support including Risk Assessments and Design-of-Experience (DoE) study design
  • GMP Audits and inspection readiness assessment and support

Drug Substance process development

  • Drug substance formulation
  • Manufacturing process
  • Design of stability studies
  • Writing and reviewing of documentation

Drug Product formulation & process development

  • API-excipient compatibility studies and early phase: “fit for purpose” formulations
  • Formulation of parenterals, oral solid dosage forms and lyophilized products
  • Immediate, delayed and prolonged release formulations
  • Process design and validation
  • Design of stability studies
  • Writing and reviewing documents

Analytical Development

  • Selection of methods, method development, qualification and validation, and method transfer
  • Designing and evaluation of product stability studies
  • Design and evaluation of method qualification, validation and transfer studies
  • Design of comparability studies
  • Product specification setting
  • Writing and reviewing of documentation

Learn more about Chemistry, Manufacturing and Controls (CMC) Consultancy

Ready to see how Venn Life Sciences could speed up your drug development program?
Get in touch.

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